Abbott Recalls Alinity i Ferritin Reagent Kits Due to Manufacturing Defect
Abbott Ireland Diagnostics Division is recalling 216 units of Alinity i Ferritin Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of the reagent cartridge that could lead to instrument malfunction, but no direct patient injury or illness is reported.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling 216 units of the Alinity i Ferritin Reagent Kit, List Number 07P6530. The product is a chemiluminescent microparticle immunoassay used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
The recall is due to a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
The affected units were distributed in the United States to the states of Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia. The specific lot numbers are 91532UI00 and 93238UI00. Users should check their inventory for these lot numbers and stop using the affected reagent kits.
The recalled product
- Product
- Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
- Manufacturer
- Abbott Ireland Diagnostics Division
- Affected units
- 216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/ Lot Numbers: (01)00380740131487 (17)190730(10)91532UI00/91532UI00
- (01)00380740131487 (17)190905(10)93238UI00/93238UI00
Distribution
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